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FDA Corrects Rule on BLA Safety Test Requirements

09/10/2014

Federal Register Proposed rule: FDA is correcting a proposed rule entitled “Revocation of General Safety Test Regulations Th...

OMB OKs Info on Testing Communications on Biologics

09/10/2014

Federal Register Notice: FDA’s collection of information entitled “Testing Communications on Biological Products&rdquo...

Guidance on Unique Device ID System

09/10/2014

Federal Register Notice: FDA is making available a guidance for industry, Unique Device Identification System: Small Entity Compli...

Dengue Virus Tests into Class 2

09/10/2014

Federal Register Final order: FDA is classifying dengue virus nucleic acid amplification test reagents into Class 2 (special contr...

Panel to Discuss Watchman Cardiac Implant

08/26/2014

Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 10/8, fr...

Panel to Discuss Gene Therapy Guidance

08/25/2014

Federal Register Notice: FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will meet 11/6 from 9 a.m. to about 4:...

FDA Corrects Device Reg Errors

08/25/2014

Federal Register Final rule: FDA is amending certain medical device regulations to correct minor errors in the Code of Federal Reg...

FDA Renews Advisory Committee Charters

08/25/2014

Federal Register Notice: FDA is renewing 15 agency advisory committees for an additional two years beyond charter expiration date....

Sular Not Withdrawn for S&E

08/25/2014

Federal Register Notice: FDA has determined that Sular (nisoldipine) extended-release tablets, 10 mg, 20 mg, 25.5 mg, 30 mg, and 4...

Hemoglobin A1c Test into Class 2

08/25/2014

Federal Register Final order: FDA is classifying hemoglobin A1c test system into Class 2 (special controls). The special controls ...